Cleared Traditional

Zynex Monitoring System, Model CM-1600

K223217 · Zynex Medical, Inc. · Cardiovascular
Jun 2023
Decision
242d
Days
Class 2
Risk

About This 510(k) Submission

K223217 is an FDA 510(k) clearance for the Zynex Monitoring System, Model CM-1600, a Plethysmograph, Impedance (Class II — Special Controls, product code DSB), submitted by Zynex Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on June 16, 2023, 242 days after receiving the submission on October 17, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number K223217 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2022
Decision Date June 16, 2023
Days to Decision 242 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSB — Plethysmograph, Impedance
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2770